JP2024529166A - Microneedle device and method for detecting at least one force acting on a microneedle array - Patents.com - Google Patents

Abstract

The present invention relates to a microneedle device 10, particularly a manually applied microneedle device 10. The microneedle device 10 comprises a microneedle array 12 and a sensor device 14 coupled to the microneedle array 12. The sensor device 14 is configured to detect at least one force acting on the microneedle array 12. The present invention further relates to a method for detecting at least one force acting on the microneedle array 12 using the sensor device 14 coupled to the microneedle array 12. The present invention further relates to a method for applying the microneedle array 12.

Description

The present invention relates to a microneedle device and a method for detecting at least one force acting on a microneedle array.

In addition to typical forms of administration of active ingredients, such as swallowing a drug or injecting a drug, there is the concept of applying active ingredients through the skin. In this context, the use of microneedles has been of particular interest.

Microneedle arrays, also called microarrays, generally comprise a number of microneedles arranged on or connected to a support element such as a patch, plaster, etc. Such microneedle arrays comprise a large number of microneedles, for example 100-600 needles per ^cm2 . Due to the short length of the needles, when they are pressed into the patient's skin, they penetrate the skin only to the extent that nerves and blood vessels are as far away from the needle tip as possible. The microneedles contain an active ingredient or drug. The corresponding active ingredient may be applied to the surface of the needle or may be contained within the needle. The needles are preferably made of a material that dissolves in the skin.

For successful application of microneedle arrays, and in particular for successful drug treatment with microneedle arrays, it is important to introduce the microneedle array accurately into the desired skin layer. Here, it is particularly important to reach a sufficient insertion depth during application.

DE 102014201605 A1 describes a microneedle device with a reservoir that bursts under a certain contact pressure to release a colored liquid indicating successful application. Due to its size and/or configuration, it is a disadvantage that such indication of application is only visible after use.

Another factor in the successful application of microneedle arrays is the application time, so they need to be applied for a long enough time to release the active ingredient. In particular, the combination of insertion depth and application time is important, i.e., whether the application is done at a sufficient insertion depth and for a sufficient time.

Furthermore, skin-specific factors are relevant to application, particularly with respect to optimal insertion depth and/or application time. There are significant differences in each user's specific skin, e.g., due to age, skin texture, disease, BMI, etc. These factors affect, for example, the force required to reach the insertion depth.

The object of the present invention is to provide a microneedle device and method that can improve the testing of microneedle array applications.

According to the present invention, this object is achieved by a microneedle array according to claim 1 and a method according to claim 13.

The microneedle array according to the invention is in particular a microneedle array for manual application. Here, manual preferably means that the microneedle array of the microneedle device can be applied manually by a user, in particular using one or more fingers or hands. The microneedle device is preferably configured for application using the thumb of the user. Thus, preferably, no application device, in particular a force application device, is required for application. On the other hand, the microneedle device may alternatively be a microneedle device that is applied, in particular using a force application device. The microneedle device comprises a microneedle array. The microneedle array comprises a plurality of microneedles. The microneedles are preferably cone-, pyramidal- or obelisk-shaped. The microneedles are connected, in particular integrally, to a support element. The microneedle device further comprises a sensor device that is connected, for example adhesively, to the microneedle array. The sensor device is connected indirectly or directly to the microneedle array. The sensor device is preferably connected to the side opposite the tip of the microneedle, which may also be referred to as the rear side. The sensor device is preferably connected, in particular directly, to the support element. The sensor device is configured to detect at least one force acting on the microneedle array. The sensor device is preferably configured to detect at least one force acting on the microneedle array in a direction substantially perpendicular to the microneedle array. Instead of or in addition to detecting a force, the sensor device is configured to detect at least one pressure acting on the microneedle array. The sensor device is preferably configured to measure at least one force acting on the microneedle array, in particular to perform force measurement detection of various magnitudes. The sensor device measures the at least one force, in particular as a value in units of N (Newton) or Pa (Pascal). The sensor device and the microneedle array are preferably connected in a force-matching and/or form-fitting and/or bonded manner. In the case of a bonded connection, the microneedle array and the sensor device are preferably glued and/or soldered and/or welded to each other. The sensor device and the microneedle array are in particular inseparably connected, i.e. cannot be separated by preferably non-destructive methods. Therefore, the sensor device and the microneedle array are preferably only separable by separation, for example by sawing, milling and/or breaking. The sensor device and the microneedle array are in particular permanently connected. The sensor device and the microneedle array are preferably firmly connected to each other.

The sensor device is preferably configured to detect an application force and/or to detect a counterforce. The detected application force is in particular a force applied indirectly or directly by the user to the microneedle array, preferably to the support element, in order to apply the microneedle array to the skin. The counterforce is in particular a force counteracting the application force. The counterforce is preferably a force acting from the skin to the microneedle array, preferably to the microneedles. In particular the counterforce depends on the respective skin to which it is applied. In general it can be assumed that the counterforce increases during application until the microneedle array penetrates the skin. Thereafter the counterforce decreases until the microneedle array is in particular fully applied. As soon as the application force is no longer applied it can be assumed that the microneedle array is pushed out of the skin by the counterforce of the skin. It is therefore advantageous for the microneedle device of the invention to detect a skin-specific condition by detecting the counterforce and in particular to make it possible to adapt the application, preferably the application force, to the skin-specific condition.

The sensor device preferably has at least one force sensor or is preferably formed by at least one force sensor. It is particularly preferred that the at least one force sensor is a piezoelectric force sensor. In particular, the force sensor is a piezoelectric disc. The piezoelectric disc may, for example, be of the type EPZ-20MS64W. The piezoelectric disc is preferably circular.

The sensor device preferably comprises two force sensors, in particular two piezoelectric discs. Preferably, one force sensor is configured and/or arranged to detect an applied force and one force sensor is configured and/or arranged to detect a reaction force.

The sensor device preferably has a support structure. The support structure is in particular configured cylindrically. The cylindrical shape of the support structure can be circular, elliptical, square, rectangular or triangular. Preferably, the support structure can be a hollow cylinder. The support structure is in particular configured to transmit forces and/or to accommodate at least one force sensor. It is preferred that at least two, preferably all of the following conditions are met: the cylindrical base of the support structure substantially corresponds to the area of the support element; the cylindrical base of the support structure substantially corresponds to the area of the at least one force sensor; the area of the support element substantially corresponds to the area of the at least one force sensor. It is preferred that the force sensor is in particular directly connected to the base of the support structure. In particular, it is preferred that the other base of the support structure is directly or indirectly connected to the support element of the microneedle array. The support structure and/or the sensor device are in particular configured substantially rotationally symmetrical.

Preferably, two force sensors are connected to the support structure opposite each other. Here, the two force sensors are in particular spaced apart by the support structure. It is preferred that one of the force sensors is in particular directly connected to the base of the support structure, while the other force sensor is in particular directly connected to the other base of the support structure. It is preferred that one of the force sensors is connected on one side to the support structure and on the other side to the microneedle array, in particular to a support element.

The sensor device is preferably connected to the rear side of the microneedle array, in particular in a two-dimensional manner. In particular, the rear side is a surface of the support element. It is preferred that a force sensor or a support structure is connected to the support element.

The microneedle device preferably comprises a processing device for evaluating the at least one force detected. In particular, the processing device has a processor. The processing device is preferably connected to the sensor device, in particular to transmit information. The connection between the processing device and the sensor device is preferably wired and/or wireless, for example via Bluetooth® or WiFi®. It is possible that the processing device is part of a mobile device, such as a smartphone.

It is preferred that the processing device is configured to compare at least one detected force with a target force. The target force is in particular 10 N to 100 N. In particular, the target force is a force necessary for application, preferably a predetermined force. It is preferred that the target force is at least a minimum force necessary for application. Alternatively or additionally, it is preferred that the processing device is configured to record the time at which the force is applied to the microneedle device, in particular the microneedle array. It is preferred that the processing device is configured to compare the time at which the force is applied with a target time for application, in particular a predetermined target time. In particular, the target time is between 3 and 300 seconds. It is particularly preferred that the processing device is configured to record the applied force over time and preferably to compare it with a target value. In particular, the processing device is configured to detect the achievement of the target force by the detected force and/or to detect the achievement of the target time by the application time, and it is preferred to detect the achievement of the target force over the target time. If the detected force corresponds to at least the target force over a certain time up to the target time, in particular at least up to the target time, the target force is reached over the target time. Preferably, the target force is reached over the target time, if the detected force corresponds to the target force in one time interval, i.e. continuously, or in total, i.e. over a cumulative time, at least until the target time is reached. Preferably, the processing device is configured to record the detected force and/or the time. Preferably, the processing device is configured to compare the applied force with the counterforce, which allows, for example, to incorporate skin-specific characteristics. Preferably, the processing device is configured to determine a target force for the applied force as a function of the counterforce.

The processing device is preferably configured to send feedback to the person regarding the application of the microneedle array using the microneedle device. In particular, the person is a user. The processing device is configured to send feedback when a target force is reached by the detected force and/or when a target time is reached by the application time. It is particularly preferred that the processing device is configured to send feedback when a target force is reached over the target time. When the target time and/or the application time and/or the target force is reached, preferably a signal is output for the target time, in particular an acoustic signal and/or an optical signal and/or a tactile signal.

Preferably, the microneedle device comprises a feedback device for transmitting, preferably outputting, feedback, in particular an acoustic feedback device and/or an optical feedback device and/or a tactile feedback device. The feedback device may comprise an optical device, e.g. an LED, and/or a speaker. The feedback device may further comprise an actuator, e.g. a vibration element. The feedback device is preferably configured to output feedback in case of successful and/or unsuccessful application. In particular, the feedback output in case of successful application is different from the feedback output in case of unsuccessful application. The feedback device is preferably connected to a processing device, in particular to transmit information. The connection between the processing device and the feedback device is preferably wired and/or wireless, e.g. via Bluetooth or WiFi. It is possible that the feedback device is part of a mobile device, such as a smartphone.

The microneedle device preferably has a finger application surface for manual application of the microneedle array with at least one finger of a user. The finger application surface is preferably a thumb application surface for application of the microneedle array using the thumb. In particular, the finger application surface has substantially the size of a human finger, preferably a thumb. The finger application surface is in particular integrally connected to, and preferably corresponds to, an exposed surface of a force sensor of the microneedle device. The finger application surface is preferably planar.

The microneedle device, and in particular the sensor device, is preferably configured so that an applied force, e.g. an applied force applied to a finger application surface, is uniformly transmitted to the microneedle array.

Furthermore, the present disclosure further relates to a method for detecting at least one force acting on the microneedle array using a sensor device coupled to the microneedle array. The detected force is in particular an applied force, preferably a user's manually applied force and/or a reaction force on the microneedle array.

The method for detecting at least one force acting on a microneedle array is preferably carried out using a microneedle device having one or more of the features of the microneedle device described above.

The present disclosure further relates to a method for applying a microneedle array. The method comprises the step of applying a microneedle array to the skin of a patient. The application is performed in particular manually or using an application device. The method further comprises the step of detecting, in particular measuring, at least one force acting on the microneedle array by the above-mentioned method for detecting at least one force acting on the microneedle array. The detected force is in particular an application force, preferably a manual application force of a user and/or a reaction force on the microneedle array. Optionally, the method comprises the further step of evaluating the at least one detected force. In the evaluation, in particular the detected force is compared with a preferably predetermined target force for application. Another optional step of the method is outputting feedback regarding the at least one detected force. The output of the feedback is preferably performed immediately when the detected force reaches the target force, in particular over a period until a target time is reached. The output of the feedback is preferably tactile and/or optical and/or acoustic.

The method for applying the microneedle array is preferably carried out using a microneedle device having one or more of the characteristics of the microneedle device described above.

The present invention will now be described in more detail with reference to preferred embodiments thereof with reference to the accompanying drawings.

1 is a schematic cross-sectional side view showing an embodiment of a microneedle device according to the present invention during application. 1 is a schematic side cross-sectional view showing another embodiment of a microneedle device according to the present invention. 1 is a schematic side cross-sectional view showing another embodiment of a microneedle device according to the present invention. 1 is a schematic side cross-sectional view showing another embodiment of a microneedle device according to the present invention.

In the drawings, similar or identical parts or elements are identified by the same reference numbers or variations thereof (e.g., 16 and 16', 16"). In particular, to improve clarity, elements that have already been identified preferably do not have reference numbers in all of the drawings.

Figure 1 is a schematic side cross-sectional view showing a microneedle device 10 during application.

The microneedle device 10 comprises a microneedle array 12 having a support element 20, such as a patch, with a plurality of microneedles 22 in particular integrally connected to the support element 20.

The sensor device 14 is connected, for example adhesively, to the rear side 40 of the microneedle array 12, which in this case corresponds to the surface of the support element 20. The sensor device 14 is shown as having one force sensor 16, in particular consisting of one force sensor 16. In particular, the force sensor is a piezoelectric force sensor 16. The piezoelectric force sensor 16 is preferably a piezoelectric disc, in particular a circular disc.

The microneedle device 10 is shown being applied, for example, to the patient's skin 104, by the thumb 102 of a hand 100 of a user, for example a patient or healthcare professional. Here, an application force (indicated by arrow 24) is applied by the thumb 102 to the application surface 38 of the microneedle device 10, thereby inserting the microneedles 22 into the skin 104. The application force 24 may be applied for a period of time, for example to further press the microneedle array 12.

The applied force 24 can be detected, in particular measured, by the force sensor 16.

The skin 104 acts against the insertion with a counter force (indicated by arrow 26) against the microneedle array 12.

The microneedle array 12 and/or the sensor device 14 have in particular a circular, elliptical, rectangular or square base. Preferably, the microneedle array 12 and/or the sensor device 14, particularly preferably the microneedle device 10, are symmetrical, in particular rotationally symmetrical.

Figure 2 shows another embodiment of a microneedle device 10 according to the present invention.

The sensor device 14 is shown to have two force sensors 16', 16'', particularly of the piezoelectric type, spaced apart by a hollow cylindrical support structure 18. In particular, the support structure 18 has a circular base.

The reaction force 26 can be detected via a force sensor 16" that is directly coupled to the microneedle array 12, while the applied force 24 can be detected via a force sensor 16' that is specifically and integrally coupled to the application surface 38.

During application, an application force 24, for example from the thumb 102, acts on the microneedle array 12. This application force 24 increases until it reaches a target force, in particular where the microneedle array 12 penetrates the skin 104. This force, in particular the application force 24, which is equal to or greater than the target force, is then maintained for a certain time (holding time) by, for example, the thumb 102. The skin 104 continues to exert a reaction force 26 on the microneedle array 12 and thus also, for example, on the thumb 102. This reaction force 26 increases until the microneedle array 12 penetrates the skin 104. Then, the reaction force 26 decreases while the microneedle array 12 penetrates further. When application is terminated or stopped, for example when the thumb 102 is removed, the reaction force 26 is finally present. In particular, the reaction force 26 depends in particular on the respective skin 104 to which it is applied. The sensor device 14 having two force sensors 16', 16" is preferably capable of detecting the applied force 24 and the reaction force 26, thereby allowing optimal evaluation and/or adaptation of the application.

Figure 3 shows another embodiment of the microneedle device 10, which is substantially based on the embodiment of Figure 2.

In FIG. 3, force sensor 16' and force sensor 16" are connected via cables 32 and 34, respectively, to specifically transmit information to processing device 28.

The processing device 28 is particularly configured to evaluate the detection values of the force sensors 16', 16".

Feedback (represented by line 36) may be provided to the user via a feedback device 30 connected to the processing device 28. For example, feedback may be provided immediately when sufficient application force 24 has been applied, and in particular when sufficient application force 24 has been applied, preferably for a predetermined period of time.

The feedback device 30 may include, for example, a lamp, such as an LED, and/or a speaker and/or an actuator, such as a vibration element.

Instead of a wired connection of the sensor device 14 to the processing device 28, a wireless connection is also possible, such as a WiFi connection and/or a Bluetooth connection.

Figure 4 shows another embodiment of a microneedle device 10 according to the present invention, which is substantially based on the embodiment of Figures 2 and 3.

In contrast to the embodiment shown in FIG. 3, which has an external processing device 28 and feedback device 30, in the embodiment shown in FIG. 4, the processing device 28 and feedback device 30 are integrated into the sensor device 14.

Claims (15)

A microneedle device (10), in particular a manually applied microneedle device (10), comprising:
A microneedle array (12), and a sensor device (14) connected to the microneedle array (12).
It is equipped with
A microneedle device, wherein the sensor device (14) is configured to detect, in particular measure, at least one force acting on the microneedle array (12). The microneedle device (10) of claim 1, wherein the sensor device (14) is configured to detect an applied force (24) and/or to detect a reaction force (26). The microneedle device (10) according to claim 1 or 2, wherein the sensor device (14) comprises at least one force sensor (16), in particular at least one piezoelectric force sensor. The microneedle device (10) of claim 3, wherein the sensor device (14) has two force sensors (16). The microneedle device (10) according to any one of claims 1 to 4, wherein the sensor device (14) has a particularly cylindrical support structure (18). The microneedle device (10) of claim 5, wherein two opposing force sensors (16) are coupled to the support structure (18). The microneedle device (10) according to any one of claims 1 to 6, wherein the sensor device (14) is connected to the rear side of the microneedle array (12), particularly in a two-dimensional manner. The microneedle device (10) of any one of claims 1 to 7, further comprising a processing device (28) for evaluating at least one detected force. The microneedle device (10) according to claim 8, wherein the processing device (28) is configured to compare at least one detected force with a target force and/or to detect the duration of application of the force, in particular the time course of the force. The microneedle device (10) of claim 8 or 9, wherein the processing device (28) is configured to provide a person with feedback regarding application of the microneedle array (12) using the microneedle device (10). The microneedle device (10) according to any one of claims 1 to 10, further comprising a feedback device (30), in particular an acoustic and/or optical and/or tactile feedback device. The microneedle device (10) of any one of claims 1 to 11, further comprising a finger application surface (38) for manually applying the microneedle array (12) with at least one finger (102) of a user. A method for detecting at least one force acting on a microneedle array (12) using a sensor device (14) coupled to the microneedle array (12). A method for applying a microneedle array (12), comprising:
applying said microneedle array (12), in particular manually or using an application device;
A method comprising the steps of detecting, in particular measuring, at least one force acting on the microneedle array (12) using the method according to claim 13, and preferably evaluating the at least one detected force and/or outputting feedback regarding the at least one detected force. The method according to claim 13 or 14, which is carried out using a microneedle device (10) according to any one of claims 1 to 12.

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